Risk Management Lead
1 month ago
General Description:
The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development, follow up on quality signals, issues and open actions and contribute to the advancement of the RBQM program.
Essential Functions of the Job:
- Provides assigned study teams with onboarding training and tools to aid in the adoption of RBQM.
- Facilitates risk management with the relevant stakeholders for identification of critical to quality factors, and identification, evaluation, control, communication, review and reporting of risks.
- Collaborates with CRAs, Central Statistical Monitors, Data Management, vendors, process owners and others as needed to analyze risks and issues using quality performance data, to identify follow up actions and to oversee completion of identified actions.
- Drafts, maintains, and archives the documentation of risk management activities e.g., risk/issue(s), controls, findings, escalations, tracking and resolution utilizing RBQM tools and following BeiGene SOPs.
- Trends risks and issues across related entities.
- Supports the study team and other contributors to clinical development in optimization of controls applied based on risk evaluation. For example, optimizing the application of source data verification and source document review.
- Supports the study team in optimizing the RBQM model including acting as a change champion and subject matter expert for a risk-based environment.
- Develops and leads culture change and communication activities with stakeholders.
- Conducts ad hoc risk assessments as needed to support clinical development.
- Additional activities as needed to support business goals.
Qualification Required:
Supervisory Responsibilities:
- Matrix influence across levels, functions, countries and time zones
Computer Skills:
Windows, Offices, Analytics Tools
Other Qualifications:
- 5-10 years leading risk assessments in the pharmaceutical industry
- Prior experience deploying risk-based quality management programs across clinical development preferred
- Ability to work independently to complete management and oversight activities
- Experience working and communicating within cross-functional teams
- Knowledge of overall clinical trial management process, understanding of the protocol and other clinical trial related plans and documents
- Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data
- Therapeutic area specific experience and knowledge – Oncology/Hematology preferred
- Ability to use the relevant technology and risk-based tools/platforms effectively
- Proven track record in delivering agreed results against a plan and timeline
- Understanding of ICH and regulatory environment
- Problem-solving skills
- Self-management skills
- Ability to work in global team environment
Travel: 0-20%
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Applicant Privacy Statement:
BeiGene is committed to respecting and protecting the personal information rights of applicants, and promises to handle applicants' personal information (including sensitive personal information, if any) in accordance with the principles of legality, legitimacy, necessity, and good faith. For more details, please refer to BeiGene's Applicant Privacy Policy.
Due to the reasonable business need for human resource management as a result of BeiGene's global operation, job applicants' resume and job application relevant information may be provided to the BeiGene affiliate (BeiGene Ltd.), and the aforementioned data will be stored in Workday (currently located in the U.S.). If the job applicant wishes to exercise his/ her personal information rights provided under PRC laws, he/ she may contact BeiGene Ltd. via
When you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to BeiGene's Applicant Privacy Policy and relevant personal information handling rules (especially the provision of personal information to countries outside of China).
When you voluntarily provide other applicants' personal information to us, it is deemed as you confirm that relevant personnel have acknowledged and consented to BeiGene's Applicant Privacy Policy and relevant personal information handling rules (especially the provision of personal information to countries outside of China).
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